USPTO Patents Application 10762683

/4MERK24N HEALTH CONSULT/lNrS ®

Endovascular grafts, stents drive
interventional radiology growth

The 21st Annual Scientific Meeting of the Society of Cardiovascular and
Interventional Radiology (SCVIR), held in Seattle, Washington, early this month,
highlighted important emerging segments of the interventional radiology market,
including endovascular grafts for the treatment of aneurysms, dissections, and other
vascular defects, as well as vascular stents for the treatment of vascular occlusive dis-
ease. Interventional radiology is a rapidly expanding discipline, as evidenced by
growth in attendance at the annual SCVIR conference:
professional registration increased from 1,474 in 1994 to
2,154 in 1996. That data also underestimates the actual
increase in clinicians performing interventional radiology
procedures, since both interventional cardiologists and, to
a lesser extent, vascular surgeons, are beginning to treat
their patients with interventional radiology techniques.

The trend for multiple disciplines to become involved in
this field is indicated by the distribution of sales of percuta-
neous translurninai angioplasty (PTA) balloon catheters: in
1995, interventional radiologists purchased 71% of the
devices, cardiologists purchased 15%, and vascular sur-
geons purchased 14% of the total units sold in the US. Although the entry of other spe-
cialists represents a threat to interventional radiologists, for suppliers the trend will
expand the market for interventional radiology products, since referral patterns, par-
ticularly referrals from vascular surgeons, will diminish as a limiter of expanded use.

Emerging graft and stent applications

Vascular stents are revolutionizing the field of interventional cardiology, and
are being used in 30% to 50% of percutaneous coronary revascularization proce-
dures in some centers in the U.S. and Europe. Johnson & Johnson Interventional
Systems (Warren, New Jersey), the dominant supplier of coronary stents, achieved
estimated sales of $450 million worldwide in 1995, following Food and Drug
Administration (FDA) approval of the Palmaz-Schatz coronary stent in August
1994. iMore than 300,000 Palmaz-Schatz coronary stents have been implanted
worldwide since the device was introduced. Stents for peripheral vascular applica-

- Please see ENDOVASCULAR, page 2

CDU at the
Society of
Cardiovascular

and
Interventional
Radiology

Wittt this issue: ai

oir FDA reform:

The pulse

□ Artificial blood vessel devel-
opments reported in Japan.
See Report from Japan, page
6.

□ InControl files IDE for its
Metrix atrial defibrillation
device. See Business Devel-
opments, page 7.

□ Focal Inc. makes two man-
agement appointments. See
Personnel File, page 8.

□ Blood-thinning proteins are
eyed in thrombosis fight.
See Market Updates, page 9.

□ Beckman Instruments com-
pletes acquisition of Hybri-
tech Inc. See Acquisitions &
Agreements, page 10.

□ St Jude starts trials on new
X-Cell, SJM Masters Series
-valves. See Product Pipeline,
page VL

□ InStent posts gains in rev-
enues in quarter. See The
Bottom Line, page 12.

ATPRESSTTMESonus Pharma-
ceuticals (Bothell, Washington)
has completed patient enroll-
ment in a pivotal Phase HI trial
of EchoGen Emulsion, an ultra-
sound contrast agent for use in
echocardiography. The trial,
which involves 244 patients at
19 clinical sites in the US., will
complete Sonus's clinical data
base for both cardiology and
radiology indications for the
product in a new drug applica-
tion. Radiology trials also are
under way at five centers in
Germany, France, Italy and the
United Kingdom.

tJfcbT AVAiLADLt: our \

Page 2 . _ ^Cardiovascular Device Update-

ENDOVASCULAR ( „ mpi8el

March 1996

hons have been on the market for a considerablv ioneer
period of time (the Palmaz stent was approved for iliac
artery applications in September 1991), but total implants
are less than tor the coronary stent due to the lower num-
ber ot penpheral angioplasty procedures as compared to
coronary procedures. However, the use of stents in the
penpheral vessels, primarily the iliac and femoral arteries
continues to expand, with Johnson & Johnson Interven-
honal's Palmaz stent now being emploved in 24% of
revascularization procedures for which 'this device is
approved (treatment of common and external iliac arterv
stenosis, and treatment of common bile duct and hepatic
bile duct strictures). J&J Interventional will be part of the
Cordis (Miami Lakes, Florida) unit of Johnson &
Johnson as the interventional cardiology powerhouse is
tormed in the wake of the Cordis merger into J&J

The Wallstent, manufactured by Schneider (USA)
Inc. (Minneapolis, Minnesota), a division of Pfizer Inc
(New York), is the other stent commonlv used in inter-
ventional radiology procedures in the US. The Wallstent
is not yet approved for vascular appl ications, although

Table 1

Potential Patient Populations for Applications of
Penpheral Vascular Stents and Endovascular Grafts

Disease
Category

Number of

Patients

Requiring

Therapy

Annually*

Patients
Treatable With
Stents or
Endovascular
Grafts (Est) b

Applicable
Device

Femoral/
Iliac Stenosis

Carotid artery

Abdominal
aortic aneurysm

Other aneurysms
(thoracic, iliac,
other)

Other vascular
stenosis

Trauma-induced
arterial lesions

140,000

200,000*
44,000

37,000

60,000
10,000

25%-30% Stent or graft

25%-30%
70%

70%

25%-30%
70%

Stent

Endovascular
graft

Endovascular
graft

Stent

Total

491,000

a either surgical or interventional procedure

Source: Cardiovascular Device Update

approval appears ixnminent The device is approved for
treatment ot malignant biliary strictures and is available
for investigational use for transjugular intrahepatic por-
tosystemic shunt (TIPS) procedures.

However, the potential market for peripheral vas-
cular stents may prove to be far larger than current
sales would indicate. Potential new applications in the
treatment of carotid artery stenosis could expand uti-
ization more than threefold, as indicated in Table 1
In addition, the newly emerging area of endovascular
stent-grafts promises to open up a related market that
may rival the size of the peripheral vascular stent
market, with as many as 100,000 patients being poten-
tial candidates for the use of endovascular grafts.

Applications of stents in the peripheral vessels
include treatment of lesions unsuitable for angioplasty
management of dissection and recoil following angio-'
plasty and treatment of late angioplasty failures due to
restenosis. In addition, a varietv of non-vascular appli-
cations exist such as treatment of esophageal strictures
(the Cook-Z Esoph ageal stent was just introduced at the

" SCVIR conference); treatment of bil-
iary and renal strictures, and TIPS.

Results with the Palmaz stent in
the iliac arteries to date have been
suboptimal, according to Dr. Gary
Becker of Baptist Hospital (Miami,
Florida), one of the leading experts
in interventional radiology. In
addition, a trial employing the
Palmaz stent in the femoral arteries
(Femoral Artery Stenting Trial, or
FAST) was recently halted in part
because of issues with compression
of the stent as well as due to prob-
lems with patient enrollment.

The Palmaz stent lacks longitu-
dinal flexibility, limiting delivery
options in the peripheral arteries,
and is subject to permanent defor-
mation if compressed. However,
iliac artery stenting with the
Palmaz stent probably provides
improved results as compared to
angioplasty alone, since stenting
provides an excellent immediate
result in many cases that would
otherwise be angioplasty failures or
ead to suboptimal results, includ-
ing chronic occlusions, severe dis-
sections, and severe recoil. Other
stents under development for use
in peripheral vessels are described
in Table 2 on page 3. Many of those

Potential
U.S. units
per year 4

63,000

90,000
30,000

26,000
27,000

Stent or graft 10,000

246,000

ecopyrigm 1996 by American Health Consultants*. Unaumorizeti ono ^^

March 1996

Cardiovascular Device Update^

Page 3

Table 2

Stents and Endovascular Grafts Under Development for Peripheral Vascular Use

Company

Product

Key Features

Status

AngioMed/
C.R. Bard

(Karlsruhe, Germany)

Memotherm

Cook Inc.

(Bloomington,

Indiana)

Fontaine-Da ke
Stent

Cook-Z Stent

Covered Z-Stent
(Chuter)

Fontaine-Dake

Cordis/ Cordis Stent

Johnson & Johnson
(Miami Lakes,

Florida)

Palmaz Stent

PTFE-covered
Palmaz Stent

InStent Inc VasuCoil
(Eden Prairie,
Minnesota)

Medi-tech/ Strecker Stent

Boston Scientific
(Natick, Massachusetts)

Medtronic Wiktor Stent

Interventional Vascular
(San Diego, California)

Nitinol Medical Nitinot Stent
Technologies/Bard Radiology
(Covington, Georgia)

Schneider (USA) Wailstent

(Plymouth,

Minnesota)

SciMed/ Scimed/
Boston Scientific Organogenesis

(Minneapolis,
Minnesota)

Stent-Graft

Self-expanding nitinol stent with no foreshortening on
expansion; ureteral versions available in Europe; versions
under development for TIPS, iliac, and biliary applications

Balloon expandable, biocompatible stent with high mech-
anical flexibility in both compressed and expanded forms:
capable of 180-degree bend; intermediate in hoop strength
between Palmaz stent and Wailstent
Self-expanding; stainless steel; wire bent in Z-pattem and
joined at ends to form a cylinder
Z-type stents at either end of Dacron graft

Tantalum balloon-expandable stent covered with
polyurethane or parylene

Balloon expandable; tantalum; flexible in undepioyed
state and rigid in deployed state; 4mm to 12mm deployed
diameter; 15mm to 70mm deployed length
Slotted tube design; balloon-expandable stainless steel
stent; shown to inhibit restenosis in coronary vessels

Both partially covered and fully covered designs under
evaluation with inside and outside covering

Nitinol self-expanding stent maintains lumen size after
flexure; 4mm to 9mm diameter; 40mm length; permanent
and temporary versions

Balloon expandable; constructed of interwoven tantalum
wire mesh; intermediate flexibility

Balloon expandable; tantalum; 3mm to 4mm diameter and
15mm length (coronary version); over-the-wire placement

Self-expandable using nitinol thermal memory alloy

Self-expanding; stainless steel; 25mm to 3.5mm expanded
diameter; high longitudinal flexibility; hoop strength
somewhat less than Palmaz stent

Nitinol self-expanding stent with porcine or bovine
collagen covering

IDEs under way for iliac and 510(k)
to be filed for biliary applications

Successful in biocompatibility
studies in microswine at 2 months;
if successful at 6 months, will
proceed to human trials
Experimental use in iliac arteries in
Japan

In development

In vitro model studies

Pre-clinical testing complete

Only stent approved for peripheral
vascular applications in US.; under
evaluation for other applications
Pre-clinical studies

About 200 implants worldwide for
peripheral applications; preparing
IDE filing

Preiinunary evaluation for
peripheral applications in US.;
widely used in Europe

More than 15,000 implanted world-
wide (coronary & peripheral); no
dinicals for peripheral use in US.

Pre-clinical studies

Awaiting FDA approval for vascular
use; approved for treatment of bili-
ary strictures; under evaluation for
treatment of colon strictures, main-
tenance of hemodialysis grafts

Animal studies

CorvitaCorp. Corvita

(Miami, Florida) Endoluminal Graft

Endovascular EndoGraft
Technologies (Chandbury
(Menlo Park, Hook/Stent)
California)

Dr. Andrew Cragg Cragg Endopro
MinTec (Freeport, Bahamas)

Stainless steel; self-expanding; covering material is inter- In clinical trials in US., Europe and
woven elastomeric polycarbonate urethane fibers, allowing Latin America for applications in
intimal cell migration carotid, AAAs, subclavian, iliac

axillary, superficial femoral arteries

Dacron graft anchored by proximal and distal hook/stents Conducting US. clinical trials for

treatment of abdominal aortic
aneurysms under an IDE

Self-expanding nitinol wire stent; Dacron and polyester Clinical studies in Europe

World Medical
Manufacturing
(Sunrise, Florida)

Talent

Nitinol wire; Dacron and combination Dacron-Teflon
stitched covering

Animal studies; clinical studies
being organized in Australia

Source: Cardiovascular Device Update

.tea. ^"».

Page 4

Cardiovascular Device Update"

March 1996

devices already are in use in Europe. However, all have
some limitations for peripheral vascular therapy.

Table 2 also describes endovascuiar grafts under
development for the interventional radiology market At
present, most experience with endovascuiar grafts has
been obtained with devices fabricated by clinicians them-
selves, using e xistin g stents covered with various materi-
als including PTFE (Teflon), Dacron, polyester, silicone,
polyurethane, and paryiene. However, as demonstrated
by Table 2, numerous companies have begun develop-
ment of endovascuiar grafts for peripheral vascular appli-
cations. A major application of
those devices, drawing the focus
of most initial development
efforts, is the treatment of abdom-
inal aortic aneurysms (AAAs).
AAA has an estimated US. preva-
lence of 1.7 million, but only about
190,000 cases are diagnosed each
year, including both hospitalized
patients and patients treated on an
outpatient basis. The National
Center for Health Statistics re-
ported 102,000 hospital patients
having a diagnosis of AAA in
1993, the latest year for which data
is available. Of the total of 190,000
AAA cases, about 44,000 receive
surgical treatment. Companies
developing endovascuiar grafts
have estimated that 70% of surgi-
cal patients may be candidates for
alternative endovascuiar therapy,
or about 30,000 patients per year.

Endovascuiar grafts may also
be preferred over stents for thera-
py of vascular stenosis, if the cov-
ering material has a further inhib-
itory effect on restenosis by block-
ing cell proliferation in the stent
However, the most recent studies
have not indicated that grafts per-
form better than stents in that
application, at least with existing
graft designs and materials.

Endovascuiar grafts may
also be employed as an alterna-
tive to synthetic grafts used in
peripheral vessel reconstruction
by vascular surgeons. Corvita
Corp. (Miami, Florida), one of
the leading developers of
endovascuiar grafts, has estimat-
ed that at least 125,000 autolo-
gous and 75,000 synthetic grafts
are used in peripheral proce-
dures in the U.S., representing

another 200,000 potential units per year. Overall, the
potential U.S. market for peripheral vascular stents anc
endovascuiar grafts may approach 450,000 units pi=r
year. While selling prices for endovascuiar grafts are z
subject of conjecture, since none have been introduced
to the market, it appears likely that the market could
support a price of at least $1,000 per unit given the cose
of synthetic grafts of between 5300 to over SI, 100 each-
Average selling prices for peripheral vascular stents are
approximately 5800 in the US., and the Palmaz-Schatz
coronary stent is priced at $1395.

Table 3

Vena Cava Filter Products for Interventional Radiology Applications
Supplier

Product

Key Features

List Price

Bard Radiology/
Nitinol Medical
Technologies
(Covington,
Georgia)

B. Braun/Vena
Tech (Evanston,
Illinois)

Cook Inc

(Bioomington,

Indiana)

Medi-tech/
Boston Scientific
(Natick,
Massachusetts)

Simon
Nitinol
Filter

VenaTech-
LGM

Bird's
Nest

Greenfield
Filter

Antheor

Nitinol construction allows filter to be S935
inserted in collapsed configuration; ther-
mal memory properties provide auto-
matic deployment at body temperature;
uses smallest insertion catheter (7Fr-8Fr)
of any available device

12Fr introducer system; nonmagnetic $885-5935
device; 92%-97% patency; 2% recurrent
PE; jugular or femoral approach for
placement

12Fr introducer; stainless steel device; $850
can be placed in vena cavae measuring
up to 40mm in diameter; 2.9% occlusion
rate; femoral or jugular approach for
placement

12Fr system; stainless steel and titanium $1,126
versions; 96% patency rate; only percuta-
neous filter deliverable over a guide wire

Nehaus

Laboratories Inc.
(Miami, Florida)

Protect

William Cook
Europe
(Bjaeverskov,
Denmark)

Gunther
Filter

Biocarbon-coated Phynox alloy material
enhances thromboresistance and pro-
motes biocompanbility; 98% patency
rate; 985% protection against recurrent
pulmonary emboli; for vena cava up to
34mm

Infusion catheter with expandable plas-
tic basket surrounding infusion holes to
allow trapping of clots for lysis with
urokinase; under evaluation for use as a
temporary vena cava filter

Temporary filter with attached catheter
allowing removal; for short-term protec-
tion against pulmonary embolism in
trauma patients and others not requiring
permanent implant

Not yet
approved
by FDA

$500

(approved
only for
use in
thrombo-
lytic pro-
cedures)

Not yet
approved
by FDA

Source: Cardiovascular Device Update

© Copyright 1996 by American Health Consultants®. Unauthorized photocopying or distribution is strictty prohibited by law.

Page 5

Use of vena cava fillers expands

Vena cava filters have been in use tor almost 25
vears to prevent pulmonary embolism in patients suf-
fering from deep venous thrombosis (DVT) and other
conditions predisposing to thromboembolism. The
Greenfield Vena Cava Filter, introduced in 1972 and
manufactured by Medi-tech/ Boston Scientific, is the
most widely used device, with more than 150,000 units
implanted worldwide as of year-end 1995. Table 3
describes inferior vena cava (IVC) filter products on the
market and under development. Usage of those devices
is expanding, as indicated by increases in dollar volume
sales of about 35% for the Medi-tech Greenfield filter
over the past year in some sales territories.

A number of new IVC filters have been intro-
duced recentlv or are under development, including
the Simon Nitinol filter supplied by Bard Radiology
(Covington, Georgia); the Antheor filter from Medi-
tech (not yet available in the U.S.); the Gunther tem-
porary filter under development by Cook (Blooming-
ton, Indiana); and the Protect infusion catheter, a
device that shows promise for use in temporary pro-
tection against pulmonary embolism.

About 2.5 million persons in the U.S. have a signif-
icant level of peripheral thrombosis, primarily in the
legs, and every year about 600,000 persons suffer pul-
monary embolism when clots travel from the throm-
bosed vessels to the lungs, resulting in about 200,000
deaths annually. The initial mode of therapy to treat
that condition and prevent recurrence is anti-thrombot-
ic drugs. However, for patients for whom drug therapy
is not feasible (for example, trauma patients who are at
risk of hemorrhage), IVC filters are an alternative. IVC
filters may be implanted either percutaneously (using a
catheter) or surgically It is estimated that about 25,000
filters were implanted percutaneously in 1995 in the
US, at an average price of about $1,000, resulting in a
US. market of about $25 million for percutaneous rVC
filters. An estimated 60% of IVC filters are placed per-
cutaneously with the remaining 40% placed surgically.
As a result the total U.S. market for IVC filters placed
bv both methods was about $42 million in 1995.

While IVC filters have proven effective in protect-
ing against pulmonary embolism (studies have demon-
strated that niters can provide an approximate tenfold
reduction in deaths from pulmonary embolism), some
complications such as filter occlusion and filter migra-
tion can occur, and concerns exist regarding long-term
outcome in young patients receiving filter implants. As
a result, there have been ongoing attempts to develop
temporary removable IVC filters. Devices under devel-
opment include a temporary version of the Vena Tech
filter; the Gunther temporary filter under development
bv William Cook (Europe); and the Protect infusion
catheter marketed by Neuhaus Laboratories for clot
entrapment and lysis, for which an FDA submission for
use as a temporary filter is being prepared.

The Gunther temporary filter has been evaluated
in a studv involving 29 patients conducted over a
three and one-half year period ending in January of
this year. Filters were implanted for periods ranging
from one to 14 days (6.6 days mean), with four
patients having filters in place for greater than 10
days. Although no recurrent pulmonary embolism
was observed in any of the patients based on clinical
symptoms while the filters were in place, complica-
tions were observed in 41%. Complications included
septicemia, thrombosis of the introduction vein, IVC
occlusions (three patients), and, in one case, an inabil-
ity to remove the filter, resulting in surgical interven-
tion to retrieve the device. Bacteria apparently can col-
onize the filter via migration up the attached catheter
from the percutaneous insertion site in the groin, lead-
ing to infections.

Bacterial colonization may also have been partly
responsible for the adherence of one filter to the caval
wall. The study indicated that the filter can become per-
manently attached to the caval wall by 12 days following
insertion. As a result, the investigators concluded that
only a small number of patients would be candidates for
use of this device, those having a long life expectancy
and clear indications for placement of a filter.

Device prevents distal migration of clots

A second device that has shown some promise in
an initial feasibility investigation is the Protect catheter,
developed by Neuhaus Laboratories (Miami, Florida).
The device is approved only for thrombolysis; howev-
er, it has the unique feature of an expandable basket
formed from the same material used to construct the
catheter itself that is intended to capture clots, allowing
them to be lysed and preventing distal migration of
clots that could result in embolism downstream.

As reported by William J. Miller, MD, of Riverside
Methodist Hospital (Columbus, Ohio), at the SCVIR
conference, the Protect catheter has been evaluated in
six patients who were at risk for pulmonary embolism
but were not able to tolerate thrombolytic drug thera-
py. The filter was in place for periods ranging from
three to 18 days (7.2 average), and no pulmonary
embolism occurred in any of the patients. In one case,
a clot was observed trapped in the Protect catheters
basket, perhaps indicating that the device was serving
to protect against embolism. Although a randomized
trial of the Protect will be needed to determine if it can
provide significant patient benefit with an acceptable
complication rate, this initial study was quite promis-
ing. Recent efforts within the managed care environ-
ment to mobilize patients as quickly as possible after
major surgery have increased the need for temporary
IVC filters, Miller said. The Protect already has been
used for prevention of pulmonary embolism in
Europe.

Additional new products and others under devel-

•. . . w.. * : i_i nu r*- «» — *w« I I.—.. +U~~-~~M m«.~«*w~ww* r\r rlictriht ttinn /C Gtfintfv OfOhtblted bV '<3W.

Page 6

Cardiovascular Device Update-

opment described at the SCVFR ™ t

' ^ Amolatz thrombectomv device develop u
M-rrovena Corp. (White Bear Lake mS«1w^ Y
in deanne ciiaivsis fistula lwinn esota), for use

marke^deaSc S£j JSSf JT

already have been used ouB idS £7 * ^

dcncv is 92% or greater. Z^^ZT^

ine^ite-Kite H ultrasound np^Hio

under S^^^'TJ?^ ^
York), which ma offe I 5 ^ ^ (New

dots rapid.. The d^S^.^ 0
rube with a side window thaTcolcte aS? ^
Hon created with a manualsvS,« " S suc -

cutter to macerate th^wS™ fi
also used to apply Dresstim WDe * lrie synngeis

hoa-actoted <h rom bus removal.

water jet at the tip is used to SSpt £ ^tTfp £
catheter is not vet approved for rnarte^

<™„^

Netherlands), under investigaS* * T?" 1 **
reduce restenosis following 2£|£L or T« *
procedures bv using radiation STtS 6ntmg
cell proliferation. Nuc 2*5 is te"£Jf ne0intima,
of brachvtherapy svstera LSh f S S SUppUer
worldwide. Seven TundidTthof ,n ? llations
thought to be suitable for u!e in Li? T""*
tion pr.edures. A^££5~S2^
brachytherapy represent less than 5% of saE for
Nudeotron, it is anticipated that endovascular tad
^ST* WUI 8611 for P-es similar^ SosTfor

proves efficacious. technology
and Bosto Sdendfie (Nadek, tJ£^f° M °™'>

March 19

Repo r t
from Japan

No synthetics in
new vascular graft

Several artificial blood vessel developments h*~

NatiLTr ? ^ g , rOUp ° f rese «chers from tr
National Cardiovascular Disease Center (Osaka) a-
Kyoto Prefectural University of Medici t-
devefoped a vascular graft that d oJ^^^T
matenals, but mstead only protein and cultu^sTu ~
The new graft is characterized by the fact thanheTo^

S5»CK52? makes up the ^

aJso^bally harvested and cultured from the host

txpenments made by implanting the eraft of * ^~

« w?uS? was r p,ete,y repiac< * b ^ e

g^.^ ™* merits of the new gml

a^li^^^ 6 ta " n h0St - d most ofX

any length and diameter can be made as required

shortcomin S ^ that it takes approximatelv
*ree weeks to prepare the graft, so it caraS ™ St

^^cys.hoation.Alsamemecl^calstrSfe

SSSffl? 1 ^ during 4116 period fa *2 * *

replacement of cells is in progress, requiring: reinfnrr^
ment material such as resin film § reinforce -

Researchers at Yokohama City Univereitv Medial
Faculty have developed a novel artin^ b
abuses water as a sealant. Conventional!* artiS

SSL^S ™ de ^ po,ymer «™*™t

coating it with collagen or gelatin. The bridging materi
ak such as gluferaldehyde or forraaldehyS^
coahng materials, however, are toxic toVKy so
safer bridging materials are being sought

Jz*«*? tity of water when ne s*-

S 2 s ^ ,caJI r absorbin s 700 «=» t° 3^

times ot its weight of neighboring water A small
amount of bovine collagen negativelv charged when
coated on tie interior surface of teflon grafeTvJable

tet^ f* e ^^^^space within the

Because water particles adsorbed on the surface of
*e inner wall of the graft electricallv repd eacTomef

er, while small oxygen particles are allowed to penetrate.

— - ^^ p ^ clK ^ aJ1 !^ p '

March 1996

Cardiovascular Device Update-

Page 7

The water particles relay the charge to replace them-
setves with freshlv arriving water particles to maintain
the barrier. Water.' which acts as a sealant, has no toxici-
ty or antisenecitv. eliminating the need tor bndging
material. The tests made with the graft showed no leak-
a „ e of blond three weeks after implantation in animals.
" Daiichi Pharmaceutical (Tokyo, and Sumitomo
Electric Industries (Osaka) have jointly deve oped a
vascular graft in which endothelium growth-enhancing
substances and anti-thrombotic substances are chemi-
cally immobilized. The prototype graft has been suc-
cessfully tested with dogs for fong-termpatency.

Using polvtetrafluoroethylene (EPTFE) as a sub-
strate the inner laver of the graft consists of long hber,
while the outer laver consists of short fiber, in order to
attain optimum elasticity and pliability. Fibronecta and
heparin are chemicallv bound to the substrate fibers by
means of unique hybridization technology the group
has developed. Twenty-two patent applications, includ-
ing one in the US. and Canada, have been hied.

Tenimo (Tokvo) is developing a vascular graft made
of polyester fiber coated with fibrin. Aparticubr type of
fibrin 'is used which attracts vascular cells to form a tis-
sue. A prototype graft 5 mm in diameter and 10 an long
replaced with a dog s vasculature has attained a struc-
ture and properties similar to natural blood vessels with
layers of endothelium, smooth muscle and fibroblast.
Because the graft is coated by the host s own ceUs, there
will be no rejection reaction and no formation of throm-
bus. The method allows production of grafts of any
diameter and length.

While the vascular graft market in Japan is some-
what stagnant, with annual growth of approximately
5% a major boost is expected with development of
small-diameter grafts applicable to coronary artery
replacement. Approximately 10,000 patients are esti-
mated to exist who would benefit from the bypass graft
procedure, and with an average of two vessels for
placements, a market of 20,000 vessels potentially
exists.

Microscopically observing blood flow

Nihon Kohden (Tokvo) has developed, in collabora-
tion with Kawasaki Medical School (Kurashiki,
Okavama Prefecture), a technology to directly observe
blood flow bv microscope. The new device has aneedle-
Uke probe equipped with an object lens and a CCDcam-
era whichis connected to a high-speed camera capable of
recording 200 images per second. The device allows pre-
cision calculation of blood velocity and direction of flow
by tracing marker substances such as niobium particles.

While the endomvocardium, which exerts the
greatest strength in the heart, was suspected as most
orone to creating abnormalities of blood flow, there was
no technology available to observe such a state The
new device provides a means to observe an d establi sh a
diagnosis, as well as treatment approaches. «

Ku.s-i.n-es s
DeveLo p-nr.e-n.t-s-

InControl files IDE
for Metrix system

In a pivotal step for its Metrix atrial defibrination
svstem, InControl Inc. (Redmond, Washmgton) has
filed an investigational device exemption application
with the Food and Drug Administration to begin US.
clinical trials of the device. c u„ rt i„
The request to the FDA came last month, shortly
after InControl said it had filed with regulatory author-
ities in Europe to begin clinical tnab m £ tol2
European centers. The first human implant
took place in late October 1995 in London and freest
ing and requested trials are designed to lead to receipt
later this vear of the CE mark allowing market release of
the product in Europe. InControl has estabUshed
European headquarters in Brussels. Belgium, to duect
the clinical trials and develop a marketing o^ruza^
The Metrix atrial defibrillator is designed to detect
the presence of atrial fibrillation, select the P~P« ^art-
b«rt interval and deliver a ^-energy synchroruzed
shock to convert the fibrillation to normal heart rhythm,
t can be placed and programmed by physical* using
techniques similar to those used for implanting pace-
makers.

Guidant CEO sees window of opportuiuty

Congressional oversight has led to a speedup m
medical device approvals at the Food and Drug
Administration (FDA), Guidant Corp. s <^ianapohs.
mdiana) top official said at an investors conference^
CEO Ronald DoUens said during a session a Piper
Jaffray's medical devices conference last month in New
York that there had been a recognizable change m atti-
tude at the regulatory agency but added
not yet been a fundamental change, such as would
come from legislated reforms.

DoUens said that device.companies needed toboth
take advantage of the attitudinal change to get producte
approved, and to work for substantive change by push-
ing for reform legislation. Guidant has seen numerous
net products emerge from the ^approval labym*
in the past several months, including the Ventak Mini
toplanteble defibrillator, which was approved in
December.

European companies make acquisitions

Biocompatibles International O^gJJ"
acquired Atlantis Catheter Co. (Sunnyvale, California)
Sum for $17.5 million in shares. Atlantis has a pm-

Page 8

Cardiovascular Device Update^

March 1996

duction site in Gahvay, Ireland, producing balloon
angioplasty- products, including guide wires and dila-
tion catheters. Sales in the first nine months of 1995
were just over 5600,000, with a pre-tax loss of S888,000
reported. Atlantis has not yet obtained FDA manufac-
turing and product approvals.

Biocompatibles' existing shareholders include
Johnson & Johnson [ New Brunswick, New Jersey), and
Biotechnology Investments and 31 (both London). The
company has developed improved biocompatibility
technology for implants and invasive devices based on
phosphorylcholine (PC). The substance was first identi-
fied by Professor Dennis Chapman of the Royal Free
Hospital School of Medicine (London), and is present
in the cell membrane of red blood cells in the form of
phospholipids. It is the primary natural material
responsible for biocompatibility. Biocompatibles' first
phosphorylchoiine-based product was the Proclear soft
contact lens, launched in Europe last year. Biocompat-
ibles acquired Lomart Lenses (Norfolk, Virginia) in
September 1994 to provide access to the U.S., almost
50% of the global market.

Biocompatibles has been working with five exter-
nal contract suppliers to develop a line of PC-coated
vascular and non-vascular stents. The acquisition of
Atlantis will enable the company to bring development
and manufacturing in-house, which should improve
control and significantly reduce costs.

Sulzermedica (Winterthur, Switzerland) has
acquired two companies controlled by Dr. Peter Osypka,
Osypka GmbH (Brenzach-Wyhlen, Germany) and its
US. subsidiary, Oscor Medical Corp. (Palm Harbor,
Florida). The two companies specialize in several car-
diovascular sectors, including pacemaker leads, external
pacemakers, high-frequency cardiac ablation using
radio frequencies and atrial septum occlusion devices.

The Osypka HAT300, a fifth-generation RF cardiac
ablation device widely used in Europe, now has contin-
uous intracardiac ECG recording during the ablation
procedure, as well as continuous bioimpedance mea-
surement for verification of tissue contact, and an auto-
matic temperature control. ASDOS is a double umbrel-
la system used for the non-operative occlusion of atrial

septum defects. Unusually, complete retraction of the
device can be carried out when correct positioning of
the umbrellas proves impossible.

Current sales of the two Osypka companies are
about S21 million. Sulzermedica s cardiovascular sales
are in excess of $350 million.

Cardiovascular collaboration in China

SmithKline Beecham (Philadelphia, Pennsylvania)
is taking several steps to expand its presence in China,
especially in a pair of research collaborations centered
around the molecular mechanisms of cardiovascular
and bone-disorder diseases.

A report in the Feb. 21 issue of BioWorld Today indi-
cated that SmithKline will support research at the
National Key Laboratory of Medical Genetics
(Changsha, Hunan Province) and at the Shanghai
Second Medical University/Rui Jin Hospital, and also
will establish a training program in which students and
research fellows at the institutes will spend time at the
company's laboratories in Europe and the U.S.
SmithKline's business ties with China date to a joint
venture formed in 1984. Tianjin SmithKline French
Labs Ltd. employs more than 600.

Companies ... in brief

Alexion Pharmaceuticals (New Haven, Connecti-
cut), which is developing C5 inhibitors and apogens
designed to treat acute cardiovascular disorders and
chronic autoimmune diseases, has conducted an initial
public offering of Z2 million shares at $8.25 a share,
which would raise in excess of $18 million . . . Johnson
& Johnson (New Brunswick, New Jersey) completed its
$1.8 billion acquisition of Cordis Corp. (Miami Lakes,
Florida) in late February . . . Medtronic Inc.
(Minneapolis, Minnesota) plans to build a S200 million
manufacturing plant in Israel to produce pacemaker
electrodes . . . Zoll Medical Corp. (Burlington,
Massachusetts) will make an unspecified payment as
part of settling an unfair trade practices and unfair com-
petition suit filed by Cardiotonics Inc. (Carlsbad,
California) against Zoll, with neither company admit-
ting to liability. — ."S*

Personnel File

□ InControl Inc. (Redmond, Washington) has
named W.A. Tacker Jr., MD, PhD, director of research.
Tacker joins InControl from Purdue University (West
Lafayette, Indiana), where he has been a professor in the
Biomedical Engineering Center and the School of
Veterinary Science. He has previously served as a con-
sultant to InControl. In another appointment, Gregory
M. Ayers, MD, PhD, was promoted to director of clinical
research.

□ Focal Inc. (Lexington, Massachusetts), a medical
device and drug delivery company that is developing a
vascular drug-delivery system to prevent restenosis, has
named two persons to key management positions.
David Enscore, PhD, was named vice president, devel-
opment and drug delivery, and Glenn Kazo was named
vice president, corporate development Enscore previ-
ously was with Alza Corp., and Kazo was with Enzon
Inc. and with his own firm, Kazo Associates.

<ra rtnnwrinht hv Amarinan Wealth Cir\n<zt tltant<& I tnanthnri-raH nhr>tns*>n\iina rsr Hictriht if inn ic ctrirttv nmhihited bv law.

March 1996

Cardiovascular Device Update-

Page 9

MLairket Updates

Blood-thinning proteins
eyed in thrombosis fight

A blood-sucking, iron-depleting, anemia-inflicting
nematode bearing the scientific name Ancylostoma can-
inum threatens more than L million persons in the Third
World - about one in six of the entire world population.
Paradoxically, according to a report in CDU's sister pub-
lication, BioWorld Today, that unwelcome lodger in the
bowels of humans and canines secretes proteins that
can help prevent a class of diseases that cause approxi-
mately half of all deaths in the U.S. Those range from
cerebral stroke to pulmonary thrombosis to heart attack
and beyond.

In a sense, the body has only itself to blame - not a
parasite - for those diverse lethal ailments, all arising
from the over-eager action of the life-saving coagulation
cascade. Wherever blood is spilled, from a pin-prick to
a slashing knife wound to an internal hemorrhage, the
bleeding itself signals the coagulation machinery to
switch on. The dozen or more blood-clotting factors
serially activate one after the other, like the domino
effect with the terrninal factor, the enzyme thrombin,
forming fibrin. That filamentous protein creates a mesh-
work, something like sandbags shoring up a flood-
threatened levee, to seal off the wound with blood clots.

When the cascade overdoes its wound-healing
coagulation by piling on dots (thromboses) which block
coronary arteries damaged by atherosclerosis, the result
is chronic and fatal cardiovascular diseases. For hook-
worms to make a living by feeding on human blood,
thev have to defeat the complex coagulation cascade.
They do so by deploying equally subtle blood-thirining
inhibitors against specific clotting factors.

Industrial and academic researchers are busy track-
ing down and cloning those proteins as preventive
treatment for the range of devastating thrombotic ill-
nesses.

The March 5 issue of the Proceedings of the National
Academy of Sciences (PNAS) carried a report by Corvas
International (San Diego, California) on the anticoag-
ulant repertoire of Ancylostoma caninum. Its senior
author was George Vlasuk, vice president of biological
research at Corvas. He and his associates have isolated
blood-thinning proteins in particular from A. caninum,
and created recombinant cDNA clones from three of
them, named nematode anticoagulant proteins (NAP),
for clinical development.

One of those, NAPc2, is being groomed for Phase
I/H clinical trials in the U.S. early in 1997, Vlasuk told
BioWorld Today. "We've already begun manufacture of
clinical supplies for this study, under contract/' he said.

"And we're starting to put together the necessary docu-
mentation to file an investigational new drug application
bv the end of the year for the Phase I safety study, and
take it through to a Phase II efficacy endpoint as well."

An earlier Corvas thrombin inhibitor, CVS-1123, a
synthetic small molecule, underwent a Phase I clinical
trial in the United Kingdom: it ended late last year.
Vlasuk said Corvas would present some of the data
from that study at a scientific meeting in April. "The
bottom-line results," he said,, "are very positive. The
orally delivered drug was well-absorbed in a dose-
dependent manner, with no adverse reactions."

The leading anticoagulant drug presently on the
market is low-molecular-weight heparin, marketed
under the trade name Lovenox by Rhone-Poulenc
Rorer (Collegeville, Pennsylvania). Heparin is an organ-
ic acid derived from slaughterhouse livers and lungs.

Cardiac assist system under development

Researchers at the Technion (Haifa, Israel), a
research organization affiliated with the University of
Tel Aviv, are developing a system they say can re-
place the need for implantable cardiac assist devices
and intra-aortal balloon catheters.

The system consists of an electronically controlled
vest that surrounds the patient's chest. In the cardiac
resuscitation mode, the rate and magnitude of pres-
sure pulses are dictated by the control device, but in
the cardiac assist mode, the system senses signals
from an electrocardiograph and adjusts its pulse dura-
tion and frequency appropriately.

The main applications foreseen will be to provide
emergencv assistance after a myocardial infarction,
after surgery or angioplasty and in the improvement
of blood flow to the brain and heart during cardio-
pulmonary resuscitation. The new system is non-
invasive and can be used, even by non-specialists.

Ultraf ast CT scans effective, study shows

Researchers stud ving the use of ultrafast comput-
. ed tomography (CT)'scans in detecting deposits that
clog coronary arteries have lauded the technique.

As reported in the March 1, 1996, issue of
Circulation, the journal of the American Heart
Association (Dallas, Texas), a multicenter study
found that the CT scanner accurately detected the
presence of calcium deposits in 95% of the 427
patients who proved to have heart disease.

Matthew Buddoff, MD, a cardiologist at Harbor-
UCLA Medical Center (Torrance, California) who
headed the study, said the process was "effective, safe,
relativeiv inexpensive, and very fast." The ultrafast
CT scan costs about S400 and takes about five minutes

© Copyright 1996 by American Health Consultant**. Unauthorized photocopying or distribution is strictly prohibited by law.

Page 10

March 1996

to complete, Buddoff said. The current standard modal-
ity, an exercise ECG taken while a patient jogs on a
treadmill, takes rive to 12 minutes to complete, costs up
to $400, and detects only about 70% of patients with
heart disease. Other tests that register higher rates of
detection cost anywhere from S600 to $1200.

While ultrafast CT can be a strong indicator of
artery blockage, the researchers cautioned that it
should be seen as an initial tool to determine if further
tests such as coronary angiography are necessary.

The ultrafast CT scans in the study were per-
formed with scanners made by Imatron Inc. (South
San Francisco, California). Other major CT scanner
manufacturers include GE Medical Systems
(Waukesha, Wisconsin), Philips Electronics NV
(Eindhoven, the Netherlands), and Siemens AG
'Erlangen, Germany).

The study was conducted at Harbor-UCLA
Medical Center, the State University of New York at
Buffalo, Mount Sinai Hospital (Miami, Florida), the
University of Illinois-Chicago (Chicago, Illinois), the
University of Iowa (Iowa City), and Washington
State University Medical Center (Spokane).

Acquisitions

□ Beckman Instruments (Fullerton, California) has
completed its acquisition of Hybritech Inc. (San Diego,
California), a subsidiary of Eli Lilly and Co. (Indian-
apolis, Indiana).

□ Cardiac Control Corp. (Palm Coast, Florida) and
Grupo Taper S A (Madrid, Spain) have signed an agree-

| ment for a strategic alliance in Europe and selected
! countries of the Middle East and Africa, involving dis-
tribution by Grupo Taper of Cardiac Control products
beginning with the company's current line of pacemak-
ers. Grupo Taper will assist Cardiac Control in achiev-
ing CE and ISO approvals in Europe, as well as in facil-
itating relationships with research centers as Cardiac
Control seeks to expand its single-lead technology.

□ Interactive Medical Technologies Inc. (IMT; Los
Angeles, California) has reached an agreement with E-
Z-EM Inc. (Westbury, New York) under which E-2-EM
will begin phase one animal studies of IMT's patented
contrast microsphere technology for detection of pul-
monary embolism and myocardial ischemia. IMT will
be the manufacturer of commercialized products that
emerge from the trials, while E-Z-EM will have licens-
ing rights to those products.

□ Opgal Optronic Industries Ltd. (Tel Aviv, Israel)
and GE Medical Systems (Waukesha, Wisconsin) have
reached an agreement giving GE Medical distribution
rights to a new line of imaging equipment for cardiac
surgeons. The new products, which have not yet been
introduced, are designed to help ensure that grafted

Study cites prognostic indicator

Early resolution of ST segment elevation fol-
lowing an acute myocardial infarction (AMI) is a
strong predictor of positive outcome, according
analysis from the INJECT (International Join:
Efficacy Comparison of Thrombolytics) trial. The
trial, which involved more than 6,000 AMI patients
in nine European countries, showed that adminis-
tration of the thrombolytic agent retepiase, which
is under development by Boehringer Mannheim
(Penzberg, Germany), resulted in increased inci-
dence of early resolution of ST segment evaluation.

A sub-study analysis focusing on 1,398 Germar.
patients involved in the INJECT study assessed the
results of administration of retepiase in some patient
and streptokinase in others. The extent of ST segmer.:
elevation resolution was greater in the retepiase
group, according to the study.

Dr. Rolf Schroder, one of the researchers, said th^t
administration of retepiase appeared to be a promis-
ing, non-invasive early prognostic indicator. He saic
reteplase-treated patients were indicated as having an
increased chance of survival. ~

& Agreements

blood vessels are functioning properly before open-
heart surgery is completed. Opgal is a joint venture of
Rafael, the Israeli government's armament develop-
ment authority, and Electro-Optics Industries Ltd.

□ Schering-Plough Corp. (Kenilworth, New
Jersey) has elected to pay $1 million to Corvas
International (San Diego, California) to extend until
December of this year its option to expand the research
alliance between the companies. The option covers a
development program for inhibitors of coagulation
Factor Xa, a key enzyme in the btood-dotting process.
Schering-Plough has paid $14 million to Corvas under
the alliance to develop new oral drugs for treatment of
cardiovascular disorders.

□ Texas Biotechnology Corp. (TBC; Houston,
Texas), has signed an additional agreement with
Synthelabo (Montrouge, France), a subsidiary of L'Oreal
(Paris) whereby TBC will supply data from its Novastan
clinical trials in heparin-induced thrombocytopenia/
heparin-induced thrombocytopenia and thrombosis syn-
drome (HTT/HnTS) to Synthelabo. Novastan (arga-
troban) is a direct thrombin inhibitor being developed for
use in the injectable anticoagulant market Synthelabo
will pay TBC up to $25 million for the patient data from
its ongoing trials. Synthelabo is developing a rga troban
in Europe and TBC is developing the compound in
North America for use with thrombolytics in acute
myocardial infarction and as treatment for HIT and
POTTS.

© Copyright 1996 by American Health Consultant**. Unauthorized nhntnmnvin* nr ritetrihtttinn ic ictrirtfv nrohibited bv law.

March 1996

Cardiovascular Device Update'

Product Pipeline

Page 11

St. Jude starts trials on
X-Cell, Masters valves

Clinical trials on St. Jude Medical's (St. Paul,
Minnesota) X-Cell stented porcine valve are continu-
ing in Europe, with U.S. trials to begin later in 1996.
The X-Cell valve is subjected to an anti-mineralization
process to remove potential calcification sites prior to

"^St Jude also reported initial US. implants of its
SJM Masters Series rotatable mechanical heart valve at
several US. clinical sites, which can be rotated for best
valve leaflet position after it is sutured in place. St Jude
has received CE mark approval in Europe for the mitral
version of the SJM Masters Series rotatable valve.
Elsewhere in the product pipeline:

• Amersham International (Little Chalfont,
United Kingdom) has received FDA approval for U.S.
marketing of its Myoview radiopharmaceutical agent
for functional imaging of the heart.

• Angeion Corp. (Plymouth, Minnesota) has
received an investigational device exemption from the
FDA for its radio frequency catheter ablation system,
allowing it to set up clinical studies. Up to 20 proce-
dures in up to four centers will be conducted as part
of the clinical trial. The RF catheter ablation system is
being developed to offer treatment - and possibly a
cure - for rapid heartbeats originating in the upper
chambers of the heart.

• Baxter Healthcare Corp. (Deerfield, Illinois) has
received FDA approval to market its Carpentier-
Edwards Perimount RSR tissue heart valve, designed

^ to be implanted either inside or on top of the annulus,
where the aorta joins the heart.

• Behring Diagnostics (San Jose, California), a
division of Hoechst AG (Frankfurt, Germany), has
received FDA approval for US: marketing of its car-
diac troponin I assay, designed for use with the Opus
immunoassays systems as an aide in diagnosing acute
myocardial infarction. _ v .

• The Cardiovascular Dynamics (Irvine, California)
subsidiary of Endosonics Corp. (Pleasanton, California)
has been notified that a US. patent will be issued for its
low-profile infusion catheter designed to provide greater
access to remote locations within the body and precisely
deliver therapeutic solutions for coronary, peripheral
vascular and neurovascular applications.

• Ela Medical (Le-Plessis-Robinson, France), the
pacemaker division of Synthelabo (Montrouge,
France), has placed on general release in Europe and
Japan its Opus G single-chamber pacemaker.

• Immunomedics Inc. (Morris Plains, New

Jersev) has received a US. patent for ^retargeting
methods for detecting and treating cardiovascular,
cancerous and infectious lesions.

. Medlab (Karlsruhe. Germany) has developed a
pulse oximeter board designed for OEM use that
requires onlv 90mW at 5V to operate. The board is
smaller than a credit card, and is available with a ser-
ial or analog interface and a reusable probe that is
easy to clean and sterilize.

• The Medisol Co. (Tel Aviv,. Israel) has devel-
oped a stent system that is flexible during insertion
through the arterv, but becomes rigid once it is in
place. The N1R (new intravascular rigid) flexible stent
had its first successful implantation in the heart of a
48-year-old man at Shaare Zedek Hospital (Jerus-
alem). Dr. Yaron Almagor, who performed the opera-
tion and who was responsible for the development ot
the clinical applications, said the new stainless steel
stent is a potential boon for use in patients with arter-
ies whose structural problems render the use of con-
ventional stents impossible.

. Medtronic (Minneapolis. Minnesota) has
launched the Freestyle stentless porcine heart valve in
Europe. The aortic root prosthesis is fixed using
alpha-amino-oleic acid instead of the traditional gula-
traldehyde-tanning process. Medtronic said I :wU
reduce calcification, a long-term problem with many
heart valve replacements. Medtronic's Hemopump
cardiac assist system for ventricular support is on the
market in Germany and on a limited basis elsewhere

m ^^ovoste Corp. (Morcross, Georgia) has started
clinical trials of its Beta-Cath catheter system, which is
designed to reduce the incidence of restenosis when
used immediately following a balloon angioplasty.
Novoste received an investigational device exemp-
tion last fall to conduct the study.

. Physio-Control Corp.'s (Redmond, Washing-
ton) Lifepak 10C defibrillator/ monitor/ pacemaker
now incorporates the Quick-Combo electrodesystem
designed to cut costs by using the same electrodes for
monitoring, defibrillation, and external pacing^

. Searle (Skokie. Illinois) has received FDA
approval to market its Covera-HS calcium /channel
blocker for the treatment of hypertension andangu^
with marketing to begin soon. The delivery tocolo-
gy for the drug was developed in conjunction wtfh
Alza Corp. (Palo Alto, California), which will manu-

TgZSt Upjohn inc. (London)^ ^da

new study of its blood dot-fighting drug
Swedenhasshownitcutby63%thenskofheartatta^

among patients with unstable heart disease. =>

7, T^ZZ bV Amercer, Heato Consul. Unauttonz*, photocopying or distribution is strict* proruoneo oy ,a».

Page 12

Cardiovascular Device Update-

March 1996-

The Bottom: Line

InStent posts gains in
revenues for quarter

InStent Inc. (Eden Prairie, Minnesota) has report-
ed significant increases in revenues in both the fourth
quarter and year ended Dec. 31, and lower net losses
than in year-earlier periods.

In the fourth quarter, the net loss was $597,000
down from the loss of 5649,000 reported a year earli-
er, on sales of $866,000, up from $266,000.

For the year, the net loss was $1.74 million, less
than the loss of $2.37 million in 1994, while sales
jumped to $2.4 million from $772,000.

□ The costs of accelerating the development of
Angeion Corp/s (Plymouth, Minnesota) Sentinel
implantable cardioverter defibrillator resulted in
higher net losses for both the second quarter and six
months ended Jan. 31. For the quarter, sales totaled
$267,029 compared with no sales in the second quar-
ter of the previous year, while the net loss increased to
$2.87 million from $2.24 million a year earlier. For the
six months, sales totaled $422,359, again compared
with no sales in the year-earlier period, and the net
loss increased to $5.58 million from $4.33 million in
the comparable period.

□ Revenues for Bio-Vascular Inc. (St. Paul,
Minnesota) increased 40% in the first quarter ended
Jan. 31, to $2.98 million from $2.12 million in the same
year-earlier period. Net income for the maker of spe-
cialty medical products for thoracic, cardiac, neuro
and vascular surgery was $205,000, compared with a
loss of $115,000 in the 1995 first quarter

J Medical Graphics Corp. (St. Paul, Minnesota)
has reported decreased sales and net losses in both the
fourth quarter and six months ended Dec. 31. For the
quarter, a net loss of 5164,197 was posted, compared
with income of $72,029 in the year-earlier period, on
sales of $5.7 million, down from $6.4 million in the
year-earlier period. For the year, the net loss was $1.73
million, compared with earnings of $657,865 in the
previous year, on sales of $21.6 million, down from
$23.1 million in 1994.

□ Medtronic Inc. rode what it said were continu-
ing market-share gains in its bradycardia pacing and
tachyarrhythmia management businesses to big
increases in both revenues and net income in the third
quarter and nine months ended Jan. 26. For the quar-
ter, earnings rose nearly 53% to S109.03 million from
S71.37 million a year earlier, on sales of $529.2 million,
up 28% from the S413.72 million of the year-earlier
period. For the nine months, earnings rose 51.5% to
$312.4 million from S206.17 million in the comparable
period, and sales were $1.57 million, up from $1.22
million the year before.

□ Target Therapeutics (Fremont, California)
posted big gains in both earnings and revenues in the
third quarter ended Dec. 31, with net income in the
quarter rising to $3.62 million from $1.89 million in
the comparable period, on revenues of $18.98 million
up from $12.47 million a year earlier. The current peri-
od included some SI .4 million of initial stocking
orders for the Gugliermi Detachable Coil, which was
approved by the FDA in the previous quarter. For the
nine months, earnings were $8.45 million, up from
$5.25 million a year earlier, on sales of $48.62 million,
up from $34.49 million. @.

Nexfcn^

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